NCT02522403

Brief Summary

The patients with distal radius fracture treated with immobilization (cast) and percutaneous pinning it will be to able to participate in this randomized trial. The investigators will be able to determine if the laser acupuncture is a good therapy for the rehabilitation in this type of patients. And if they are more comfortable to begin his rehabilitation exercise after the application of this therapy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 19, 2018

Completed
Last Updated

October 19, 2018

Status Verified

December 1, 2017

Enrollment Period

10 months

First QC Date

August 6, 2015

Results QC Date

October 31, 2016

Last Update Submit

December 15, 2017

Conditions

Keywords

distal radius fracturelaser acupuncturerehabilitation

Outcome Measures

Primary Outcomes (1)

  • Patient-Rated Wrist Evaluation (PRWE)

    The PRWE assesses pain and the inability to perform daily acitivities. Is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. It yields a score of 0 to 100, with lower scores indicanting better performance. Only the final results of the study are reported.

    6 weeks

Secondary Outcomes (2)

  • Wrist Mobility

    6 weeks

  • Visual Analogue Scale (VAS)

    6 weeks

Study Arms (2)

Rehabilitation

ACTIVE COMPARATOR

The investigators will be apply laser acupuncture for the rehabilitation of the wrist and hand of the patients, with the laser device in an off position, plus exercise of wrist flexion, extension, cubital and radial deviation, pronation and supination of the forearm. The investigators will be use ten different acupuncture points for treat this patients.

Procedure: Rehabilitation

Low Lever Laser acupuncture

EXPERIMENTAL

The investigators will utilize an low level laser therapy device apply into each acupuncture point. Ten acupuncture points will be used. Each acupuncture point will be irradiated for 30 seconds at 8,000 Hz.

Device: Low Lever Laser acupuncture

Interventions

The investigators will be apply fake laser therapy in the patients with distal radius fracture, with the device in an off position; plus the patients will be teaching to do rehabilitation exercise in flexion, extension, pronation and supination of the wrist and forearm, and to do cubital and radial deviation exercise. The investigators delivered to all patients a graphic demonstration of the exercise

Also known as: Physical therapy
Rehabilitation

The investigators will be used a low lever laser device, to apply in ten selected acupuncture points, each point will be irradiated for 30 seconds at 8000 Hz, this therapy is useful for tissue regeneration and stimulate the acupuncture points, plus an antinociceptive effect.

Also known as: Chinese traditional medicine, Needles Diller & Diller
Low Lever Laser acupuncture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Distal radius fracture treated with percutaneous pinning and plaster
  • Type A2, A3, B1 and B2 of the Orthopedic Trauma Association classification

You may not qualify if:

  • Rheumatoid arthritis
  • Ipsilateral fractures
  • Psychiatric illness
  • Previous wrist fracture or surgery
  • Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Autonoma de Nuevo Leon

Monterrey, Nuevo León, 64480, Mexico

Location

Related Publications (5)

  • Tahririan MA, Javdan M, Motififard M. Results of pronator quadratus repair in distal radius fractures to prevent tendon ruptures. Indian J Orthop. 2014 Jul;48(4):399-403. doi: 10.4103/0019-5413.136275.

    PMID: 25143645BACKGROUND
  • Wei XM, Sun ZZ, Rui YJ, Song XJ. Minimally invasive plate osteosynthesis for distal radius fractures. Indian J Orthop. 2014 Jan;48(1):20-4. doi: 10.4103/0019-5413.125483.

    PMID: 24600058BACKGROUND
  • Smith DW, Brou KE, Henry MH. Early active rehabilitation for operatively stabilized distal radius fractures. J Hand Ther. 2004 Jan-Mar;17(1):43-9. doi: 10.1197/j.jht.2003.10.006.

    PMID: 14770137BACKGROUND
  • Luo KM, Hou Z, Yang L. [Observation on therapeutic effect of electroacupuncture on activity disturbance of the shoulder joint after operation of fracture]. Zhongguo Zhen Jiu. 2008 Oct;28(10):727-9. Chinese.

    PMID: 18972728BACKGROUND
  • Erthal V, da Silva MD, Cidral-Filho FJ, Santos AR, Nohama P. ST36 laser acupuncture reduces pain-related behavior in rats: involvement of the opioidergic and serotonergic systems. Lasers Med Sci. 2013 Sep;28(5):1345-51. doi: 10.1007/s10103-012-1260-7. Epub 2013 Jan 5.

    PMID: 23291880BACKGROUND

MeSH Terms

Conditions

Colles' FractureRadius FracturesWrist Fractures

Interventions

RehabilitationPhysical Therapy ModalitiesMedicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Fracture DislocationJoint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesFractures, BoneForearm InjuriesArm InjuriesWrist Injuries

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesMedicine, East Asian TraditionalMedicine, TraditionalComplementary Therapies

Results Point of Contact

Title
Carlos Acosta-Olivo
Organization
Universidad Autonoma de Nuevo Leon

Study Officials

  • Carlos Acosta-Olivo, MD, PhD

    Universidad Autonoma de Nuevo Leon

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 13, 2015

Study Start

August 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

October 19, 2018

Results First Posted

October 19, 2018

Record last verified: 2017-12

Locations